FDA.reportPublic FDA data

MAUDE MDR 7335926

MDR report key
7335926
Report number
9615010-2018-00004
Event key
0
Event type
3
Date of event
2018-02-13
Date received
2018-03-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
401
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. WILLIAM GUSTAFSON
Address
5160 HACIENDA DRIVE DUBLIN CA 94568 US
Phone
925-925-9255
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OPMI LUMERA 700LUMERA 700,CARL ZEISS MEDITEC AG (OBERKOCHEN)HRMNA305953-9900-000NAN Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-03-1301. O

Event Narratives#

N

Patient 1

MANUFACTURER TRIED TO CONTACT THE CUSTOMER TO GET ACCESS TO THE MICROSCOPE FOR EVALUATION. SO FAR, THE MANUFACTURER HAS BEEN UNSUCCESSFUL IN GETTING ACCESS TO THE MICROSCOPE. MANUFACTURER'S RECORDS CONFIRM THAT DEVICE TRAINING WAS PROVIDED TO THE SURGEON AND HOSPITAL PERSONNEL ON 02/19/2018.

D

Patient 1

A HEALTH CARE PROFESSIONAL (HCP) REPORTED THAT THE RETRO-ILLUMINATION OF THE OPMI LUMERA 700 MICROSCOPE STOPPED WORKING DURING A SURGERY. THE OUTCOME OF THE PATIENT IS UNKNOWN TO THE MANUFACTURER.